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Shared Health Appointments and Reciprocal Enhanced Support (SHARES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02132676
Recruitment Status : Completed
First Posted : May 7, 2014
Results First Posted : August 19, 2020
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The purpose of this study is to evaluate the effectiveness of a peer-to-peer program (P2P) in addition to Shared Medical Appointments (SMAs) compared to SMAs alone for the treatment of diabetes in five VA health systems, and to study the implementation process in order to gather information required to disseminate the program more broadly in the VHA system.

Condition or disease
Diabetes Insipidus

Detailed Description:
Providers are often unable to communicate as frequently as needed with diabetes patients who have poor risk factor control and face significant self-management challenges. Moreover, many VA patients face barriers to attending frequent face-to-face visits. This project will evaluate the implementation of a novel program found in a recent VA randomized, controlled trial to significantly improve VA patients' diabetes-specific social support, insulin starts, and glycemic control compared to usual nurse care management. The program uses periodic group sessions in conjunction with calls between paired patients with diabetes to promote more effective care management as well as peer-to-peer (P2P) communication among diabetes patients who both have poor glycemic control and are working on similar care goals. "Peer buddies" are encouraged to talk by phone at least weekly to provide mutual support and share their progress on meeting their self-management goals. The goal of this service is to enhance the effect of shared medical appointments (SMAs), a service model demonstrated to be effective in improving outcomes among patients with diabetes and other chronic conditions and now being widely implemented in VA. Based on the success of the efficacy trial of this intervention, the investigators now seek to evaluate a wider-scale implementation of this program. During implementation of the P2P program in conjunction with shared medical appointments (SMAs) in five diverse VA facilities, the investigators will evaluate the effectiveness of SMAs alone and SMAs+P2P compared to usual care, and study the implementation process in order to gather information required to disseminate the program more broadly in Veterans Health Administration (VHA).

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Study Type : Observational
Actual Enrollment : 1536 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Peer Support to Enhance Diabetes Shared Medical Appointments: Examining Comparative Effectiveness in VA Health Systems
Actual Study Start Date : April 25, 2016
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Active treatment
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether the Peer to Peer (P2P) program was offered.
Usual Care
The randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA).



Primary Outcome Measures :
  1. Change in Glycemic Control [ Time Frame: 6 months and 12 months post-enrollment ]
    Glycemic control (measured by Hemoglobin A1c) in each group will be assessed by the comparison of an average of the values obtained during routine outpatient clinical practice in 6-month windows preceding baseline and following the 6 and 12-month post-enrollment evaluation periods. In addition to measuring absolute values of A1c, the investigators will also examine the change in the percentage of patients with an average A1c > 8%.


Secondary Outcome Measures :
  1. Change in Systolic Blood Pressure (SBP) [ Time Frame: 6 months and 12 months post-enrollment ]
    Systolic blood pressure (SBP) in each group will be assessed by the comparison of an average of the values obtained during routine outpatient clinical practice in 6-month windows preceding baseline and following the 6 and 12-month post-enrollment evaluation periods. In addition to measuring absolute values, the investigators will also examine the change in percentage of patients with an average SBP > 140.

  2. Insulin Starts [ Time Frame: 6 months and 12 months post-enrollment ]
    The number of participants who are not on insulin at baseline and are started on insulin during the 6 and 12-month post-enrollment periods will be totaled and compared for the SMA group and the no intervention control group. For the no intervention control group, baseline will be the date they are identified by the data manager. For the SMA group, baseline will be the date of the first SMA.

  3. Emergency Department (ED) Visits [ Time Frame: 6 months and 12 months post-enrollment ]
    Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits).

  4. Statin Starts [ Time Frame: 6 months and 12 months post-enrollment ]
    The number of participants who are not on a statin at baseline and are started on insulin during the 6 and 12-month post-enrollment periods will be totaled and compared for the SMA group and the no intervention control group. For the no intervention control group, baseline will be the date they are identified by the data manager. For the SMA group, baseline will be the date of the first SMA.

  5. Change in Number of Classes of Anti-hypertensive Meds [ Time Frame: 6 months and 12 months post-enrollment ]
    Change in antihypertensive use (number of classes of prescribed anti-hypertensives) in each group will be assessed at baseline and following the 6 and 12-month post-enrollment evaluation periods. For the no intervention control group, baseline will be the date they are identified by the data manager. For the SMA group, baseline will be the date of the first SMA.

  6. Change in Patient-reported Satisfaction With VA Care [ Time Frame: 6 months and 12 months post-enrollment ]

    Patients' satisfaction with VA care will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used:

    Scale name: VA Healthcare Satisfaction Scale Scale ranges: 1-6 (Strongly Disagree=1, Disagree=2, Slightly Disagree=3, Slightly Agree=4, Agree=5, Strongly Agree=6) Direction of range: Higher score indicates a better outcome


  7. Change in Patient-reported Diabetes Distress [ Time Frame: 6 months and 12 months post-enrollment ]

    Patients' level of diabetes distress will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used:

    Scale name: Diabetes Distress Scale Scale ranges: 1-5 (Not a Problem=1, Minor Problem=2, Moderate Problem=3, Somewhat Serious Problem=4, Serious Problem=5) Direction of range: Lower score indicates a better outcome


  8. Change in Patient-reported Degree of Diabetes Support [ Time Frame: 6 months and 12 months post-enrollment ]

    Patients' degree of diabetes support will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used:

    Scale name: Diabetes Support Scale Scale ranges: 1-6 (Strongly Disagree=1, Disagree=2, Slightly Disagree=3, Slightly Agree=4, Agree=5, Strongly Agree=6) Direction of range: Higher score indicates a better outcome


  9. Change in Patient-reported Degree of Self-Efficacy [ Time Frame: 6 months and 12 months post-enrollment ]

    Patients' degree of self-efficacy will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used:

    Scale name: Williams Self-Efficacy Scale Scale ranges: 1-6 (Strongly Disagree=1, Disagree=2, Slightly Disagree=3, Slightly Agree=4, Agree=5, Strongly Agree=6) Direction of range: Higher score indicates a better outcome


  10. Hospitalizations [ Time Frame: 6 months and 12 months post-enrollment ]
    Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits).

  11. Length of Hospitalizations [ Time Frame: 6 months and 12 months post-enrollment ]
    Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits).

  12. PCP Visits [ Time Frame: 6 months and 12 months post-enrollment ]
    Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits).

  13. Nurse Case Manager Visits [ Time Frame: 6 months and 12 months post-enrollment ]
    Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits).

  14. Endocrinology Visits [ Time Frame: 6 months and 12 months post-enrollment ]
    Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
VA outpatients with uncontrolled diabetes receiving care at a participating VA Medical Center during implementation of a P2P program for diabetes management in conjunction with SMAs
Criteria

Inclusion Criteria:

Veterans enrolled into diabetes Shared Medical Appointments (SMAs) at participating sites, and a random subset of those meeting criteria for diabetes SMAs who have not yet participated:

  • Veteran receiving care at a participating VA Medical Center
  • Meets at least one of the following criteria in the past 2 years;

    • at least 1 VA hospitalization with a diabetes-related International Classification Of Diseases-9 (ICD-9) code,
    • at least 2 VA outpatient visits with a diabetes-related ICD-9 code, or
    • At least 1 VA prescription for a glucose control medication (insulin or oral agent) or monitoring supplies
  • Poor glycemic control, indicated by a HbA1c in the past 6 months or:

    • at least 7.5% if age <70, or
    • at least 8% if age 70+
  • Has a current address and telephone number listed in VA databases
  • Is competent to provide informed consent
  • Can communicate in English and by telephone
  • Able to participate in an outpatient program

Exclusion Criteria:

For no intervention control group:

  • Active substance abuse disorder (smoking cigarettes is not an exclusion)
  • Serious psychiatric illness (bipolar disorder, dementia, schizophrenia, or personality disorders)
  • Terminally ill
  • Prisoner

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132676


Locations
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United States, California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
VA Northern California Health Care System, Mather, CA
Sacramento, California, United States, 95655
United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
United States, Rhode Island
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Mary Ellen M Heisler, MD MPA VA Ann Arbor Healthcare System, Ann Arbor, MI
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02132676    
Other Study ID Numbers: IIR 15-321
First Posted: May 7, 2014    Key Record Dates
Results First Posted: August 19, 2020
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Self-Management
Patient Care Management
Peer Group
Disease Management
Health Plan Implementation
Diabetes Mellitus
Additional relevant MeSH terms:
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Diabetes Insipidus
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Pituitary Diseases